BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3915550 · Received July 7, 2014

    Report

    Report Number
    2210968-2014-08676
    Event Type
    Injury
    Date Received
    July 7, 2014
    Report Date
    June 20, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THE INDICATION FOR THE PROCEDURE WAS URODYNAMIC STRESS INCONTINENCE. THE URETHRAL EROSION WAS FIRST DETECTED BY THE PHYSICIAN ON (B)(6) 2013. THE PATIENT PRESENTED WITH IRRITABLE BLADDER. THE EROSION WAS LOCATED PROXIMAL URETHRAL AND WAS SIGNIFICANT WITH ¼ OF THE URETHRA WORN. IN ADDITION, THE PATIENT EXPERIENCED AN EROSION CLOSE TO THE BLADDER NECK ON THE LEFT SIDE. THE PATIENT WAS OPERATED ON (B)(6) 2014 TO REMOVE 3MM OF MESH AND HAS HAD NO ADVERSE INCIDENCE SINCE. THE PHYSICIAN OPINED THAT POSSIBLE SHARP EDGES OF THE REMAINING MESH FROM THE PRIOR EXCISION MAY HAVE CONTRIBUTED TO THE REPEATED URETHRAL EROSION. (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN OBTURATOR SLING PROCEDURE IN (B)(6) 2013. THE PATIENT EXPERIENCED A MESH EROSION INTO THE URETHRA. A 2CM MESH SEGMENT WAS REMOVED IN (B)(6) 2013, HOWEVER, A RECENT CYSTOSCOPY SHOWED THERE WAS MORE MESH STILL IN THE URETHRA. THE PATIENT IS LISTED FOR FURTHER EXCISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393320 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC. UNK 3662821

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention